Your browser does not support JavaScript! GENTLE LAXATIVE (BISACODYL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]
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GENTLE LAXATIVE (bisacodyl) tablet
[WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

  • this product generally produces bowel movement in 6 to 12 hours
  • relieves occasional constipation and irregularity

Warnings

Do not use

if you can not swallow without chewing.

Ask a doctor before use if you have

  • a sudden change in bowel habits that lasts more than 2 weeks
  • stomach pain, nausea or vomiting

When using this product

  • do not use within 1 hour after taking an antacid or milk
  • do not chew or crush tablet(s)
  • you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.  These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical attention or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • take with a glass of water

 adults and children 12 years and over

 take 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age take 1 tablet in a single daily dose
 children under 6 years of age ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see end flap for expiration date and lot number

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polyextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

CVS
pharmacy™

Compare to the active ingredient in Dulcolax®*

Gentle
LAXATIVE
BISACODYL USP 5 mg
• Gentle yet effective
• Guaranteed relief

10 Tablets
Comfort coated

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.
50844    ORG031232703

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2014 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER  UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

CVS 44-327

CVS 44-327

GENTLE LAXATIVE 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-327
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
AMMONIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SHELLAC 
DIMETHICONE 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 44;327
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-327-032 in 1 CARTON
15 in 1 BLISTER PACK
2NDC:59779-327-337 in 1 CARTON
225 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/25/2002
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-327)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-327)

Revised: 2/2014
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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